Vitamin D Repletion in Coronary Artery Disease

This study has been completed.

Sponsor:

Seth I. Sokol, M.D.

ClinicalTrials.gov Identifier:

NCT01570309

First Posted: April 4, 2012

Last Update Posted: October 10, 2013

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Vitamin D (Vit D) status is an emerging risk marker of great interest in cardiovascular disease (CVD). Lower serum levels of Vit D are associated with both cardiac risk factors and prevalent cardiovascular disease. Vit D insufficiency remains very prevalent in free living populations in the United States especially in urban, and multi-ethnic low income Northern cities.To date, prospective randomized trials using Vit D supplementation to modify CVD risk and evaluate outcomes have not been performed.

The investigators propose a double-blind, randomized wait-list control trial in subjects with Coronary Artery Disease (CAD) and Vit D deficiency with two specific aims. Specific aim 1 is to measure endothelial function using reactive hyperemia peripheral arterial tonometry (RH-PAT) before and after treatment with Vit D replacement therapy. Specific Aim 2 is to measure levels of inflammation before and after treatment with Vit D replacement therapy. These aims will test the hypotheses that Vit D repletion will improve endothelial function and reduce the levels of detectable inflammation in the plasma of these subjects.

Further study details as provided by Seth I. Sokol, M.D., New York City Health and Hospitals Corporation:

Primary Outcome Measures:

Endothelial Function [ Time Frame: Baseline and 12 weeks ]

Endothelial function was measured using peripheral arterial tonometry expressed as the reactive hyperemia index. The index is derived from the ratio of the post-to-pre occlusion peripheral arterial tonometry signal amplitude of the tested arm, divided by the post -to-pre occlusion ratio of the control arm. Median within subject change in endothelial function as measured by reactive hyperemia peripheral arterial tonometry index in each group is presented.

Inflammation - [ Time Frame: Baseline and 12 weeks ]

Median within subject change in hs-CRP levels between baseline and week 12 in active and placebo groups

Inflammation [ Time Frame: Baseline to 12 weeks ]

Median within subject change in interferon-gamma levels between baseline and week 12 in active and placebo groups

Inflammation [ Time Frame: Baseline to 12 weeks ]

Median within subject change in cxcl-10 .levels between baseline and week 12 in active and placebo groups

Inflammation [ Time Frame: Baseline to week 12 ]

Median within subject change in IL-12 levels between baseline and week 12 in active and placebo groups

100 subjects with angiographically documented CAD and Vit D deficiency will be randomized to 50,000 IU oral ergocalciferol (active treatment group) or placebo (delayed intervention group) once a week for 12 weeks. The investigators will measure endothelial function at randomization and week 12 using RH-PAT and serologically measured adhesion molecules (s-VCAM, s-ICAM, soluble e-selectin). Changes in levels of plasma cytokines and chemokines representing a T-cell activation pathway (IL-12, IFN-g and CXCL-10 - "IFN-g axis") the investigators have linked to coronary atherogenesis (independent of CRP) and poor CV outcomes, will be measured over the 12 week study period. Given published evidence showing that Vit D can influence this T- cell pathway, specific aim 2 will add mechanistic insights to this proposal. High sensitivity C-reactive protein (hs-CRP) will be measured as it is a well established traditional marker of inflammation in CAD and has also been linked to Vit D status.

Eligibility

Information from the National Library of Medicine

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